Sr QA Officer-sterility Assurance

The role will be responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell Therapy Operations. Individual should be able to work independently with little direction to review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.

**Responsibilities**:

- Provide strategic plan and expertise for the development and implementation of the site Microbial Control Strategy.
- Develop document and manage microbial control strategy for production processes from incoming raw materials through to final product release.
- Provide oversight and sterility assurance expertise to Operations to assure aseptic processing with excellent knowledge and adherence to all relevant codes, standards and regulatory including FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820.
- Develop understanding of Cell and Gene therapy global guidelines to ensure site compliance in this area.
- Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
- Assures adequate treatment of EM deviations, adverse trends identified, CAPAs, Investigations and Complaints related to aseptic processing with Business partners e.g QA, QC and Production.
- Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications.
- Provides support and expertise to ensure that Cell Therapy (CT) and Media preparation operations and support functions applies all Sterility Assurance processes including Aseptic practices, Environmental monitoring (EM), Risk assessment and control, Cleaning and disinfection, Sterilisation, Aseptic process simulations (APS), Qualification and Validation of Equipment’s and Facilities. to confidently deliver CT products to patients with the highest quality sterility assurance level.
- Provides expert support to business partners including production, MSAT, Engineering & QC assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best EM indicator levels.
- Provides expert coaching and mentoring support locally on sterility assurance knowledge, practices and sterility awareness as part of the developing culture for the site.
- Responsible for the generation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets.
- Challenges technical and scientific aspects of the facilities design and aseptic principals, with Production, QC, and Engineering etc.
- Maintenance of specific SOPs, documentation, audits, training, cGMPS and method validation for specific area of responsibility.

**Requirements**:

- Life Science Degree or higher from recognized institution with a minimum of 5 years of QA Sterile processing and Microbial experience in similar capacity
- GMP experience in the biologics industry is required
- Working knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy required
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required
- Experience in cell culture, cell or gene therapy experience is a plus.